J&J Family of Companies Sr. Customer Quality Specialist in Santa Ana, California
Johnson & Johnson’s Vision Group within Medical Devices is recruiting for a Senior Customer Quality Specialist. Work location is flexible if approved by the Company except that position may not be performed remotely from Colorado.
At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating companies, we’ve developed solutions for every stage of life—to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world’s leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.
This position is responsible to process complaints and worldwide regulatory reports in accordance with established company procedures and applicable regulations and standards. You will intake complaints, review complaints from incoming calls, faxes, and emails from all areas of the world. You will also ensure adequate information is received to warrant timely reporting, investigation, and closure of reportable complaints, including sound regulatory reporting decisions/justifications for worldwide reporting. This position is required to maintain a high level of customer satisfaction and responsiveness to internal and external customers, affiliates as well as worldwide regulatory bodies in with regard to product complaints or inquiries.
Key Responsibilities • Be responsible for the customer complaints regulatory reporting process (timely submissions, timely closure, health authority requests etc.) • Ensures timely filing of reportable events with regulatory agencies worldwide • Provides operational leadership support to the Product Safety Group • Serves as a department lead on cross-functional teams or Divisional projects in the development of procedures and processes related to Adverse Event Reporting • Generates Adverse Event management review metrics, conducts analysis and uses data to help identify areas for process improvement • Acts as the Product Safety representative for the Risk Management process, including evaluation of on market product issues and identification of appropriate actions to mitigate risk • Provides subject matter expertise, leadership, and training as appropriate to other Complaint Owners and to those outside of the Product Safety Department that impacts the adverse event reporting process • Participates in (and presents data as needed) monthly tracking and trending review for JJSV product lines
• Bachelor’s Degree required (RN or MS preferred) • At least 4 years of experience in a medical device company or eye clinic is required • Experience handling complaints and determining reportability is required • Knowledge and experience in Ophthalmology is preferred • Working knowledge of international standards and regulatory requirements, including, but not limited to ISO 13485 and 21 CFR, section 803 and 820 is required • Excellent written and verbal communication skills are required • Demonstrated attention to detail is required • Ability to work independently as well as in a team environment is required • Strong organizational and analytical skills with the ability to multitask and consistently handle multiple projects with stringent deadlines concurrently is required • Proficiency in MS Office Suite is required • Technical aptitude and ability to explain technical information in a clear and concise manner is required • Analytical problem solving – ability to identify problems, define problem statement clearly and accurately, and apply structured and disciplined methodology to identify data-driven root causes is required
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
United States-California-Santa Ana-1700 E Saint Andrew Place
North America-United States-Florida, North America-United States-Massachusetts, North America-United States-Ohio, North America-United States-Texas
Johnson & Johnson Surgical Vision, Inc (6234)
J&J Family of Companies
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